Anti-obesity composition

Abstract

The object of the present invention is to provide a composition that is effective in preventing obesity, reducing body fat, reducing visceral fat, or reducing BMI. [Solution] The present inventors have conducted extensive research to solve the above problems and have found that by designing the daily intake of garcinol to be 10 to 50 mg / day, excellent anti-obesity effects, body fat reduction effects, visceral fat reduction effects, or BMI reduction effects can be obtained, thus completing the present invention.

Description

Technical Field

[0001] The present invention relates to a composition for anti-obesity, body fat reduction, visceral fat reduction, or BMI reduction, designed such that the daily intake of gallocatechin is 10 to 50 mg / day.

Background Art

[0002] In recent years, with the westernization of the diet and other factors, the number of obese people has been on the rise. Therefore, preventing obesity from the diet has become an issue, and the development of various anti-obesity materials that can be used in food and beverages has been underway. Such anti-obesity materials are often used as foods with functional claims. For example, a food with functional claim having a body fat reducing effect with tiliroside derived from rose hip as an involved component (Tarami Konjac Jelly 0kcal Muscat, manufactured by Tarami Co., Ltd.; notification number H368), and a food with functional claim having a body fat reducing effect with procyanidin derived from apple as an involved component (Slim Win, manufactured by DMJ Co., Ltd.; notification number I425) are known.

[0003] In developing a food with functional claim having an anti-obesity effect, it is particularly difficult to set the effective amount of the involved component (active ingredient). Even if a component shows an effect in cell tests or animal tests, it is not known how much of the component should be administered to humans to obtain an effect without actually conducting clinical trials. However, since clinical trials are extremely costly, it is usually the case to follow the known effective amount when the effective amount in humans is already known from papers or the like. On the other hand, when the effective amount in humans is not known, a clinical trial must be conducted to specify the effective amount. In that case, based on the results of known animal tests and the like, it is common to conduct a clinical trial by administering an amount that is expected to reliably obtain an effect to humans. However, since the biological structures of animals and humans are different, even if the administered amount is expected to obtain an effect based on the results of animal tests, it is often the case that the effect cannot be obtained in humans and the cost of the clinical trial is wasted.

[0004] Incidentally, garcinol is a compound found in plants such as Garcinia indica and is known to possess various physiological activities. Examples of garcinol's physiological activities include anti-ulcer effects (Patent Document 1) and antioxidant effects (Patent Document 2). However, there is no knowledge regarding the anti-obesity effect of garcinol when administered to humans, and the effective dose in humans was also unknown. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] Japanese Patent Application Publication No. 11-029465 [Patent Document 2] Japanese Patent Application Publication No. 10-121044 [Overview of the project] [Problems that the invention aims to solve]

[0006] The object of the present invention is to provide a composition that is effective in preventing obesity, reducing body fat, reducing visceral fat, or reducing BMI. [Means for solving the problem]

[0007] The inventors of this invention have diligently conducted research to solve the above problems and have found that by designing the daily intake of garcinol to be 10 to 50 mg / day, excellent anti-obesity effects, body fat reduction effects, visceral fat reduction effects, or BMI reduction effects can be obtained, thus completing the present invention.

[0008] In other words, the outline of the present invention is as follows: [1] A composition designed to provide a daily intake of 10-50 mg of garcinol for anti-obesity, body fat reduction, visceral fat reduction, or BMI reduction. [2] Contains Garcinia indica extract containing garcinol, A composition designed to provide a daily intake of 10-50 mg of garcinol for anti-obesity, body fat reduction, visceral fat reduction, or BMI reduction. [3] An oral composition containing garcinol as an active ingredient, The daily intake of garcinol is designed to be between 10 and 50 mg / day. An oral composition that is labeled as having one or more functions selected from anti-obesity, body fat reduction, visceral fat reduction, and BMI reduction. [4] An oral composition containing an extract of Garcinia indica containing garcinol, Garcinol is the active ingredient, The daily intake of garcinol is designed to be between 10 and 50 mg / day. An oral composition that is labeled as having one or more functions selected from anti-obesity, body fat reduction, visceral fat reduction, and BMI reduction. [5] A composition according to any one of [1] to [4], designed to provide a daily intake of garcinol of 10 to 40 mg / day. [6] A composition according to any one of [1] to [4], designed to provide a daily intake of 10 to 30 mg of garcinol. [7] A composition according to any one of [1] to [4], designed to provide a daily intake of garcinol of 10 to 25 mg / day. [8] A composition according to any one of [1] to [4], designed to provide a daily intake of garcinol of 10 to 22 mg / day. [9] A composition according to any one of [1] to [4], designed to provide a daily intake of 10 to 20 mg of garcinol.

[10] The composition according to any one of [1] to [4], which is designed such that the daily intake of garcinol is 10 to 18 mg / day.

[11] The composition according to any one of [1] to

[10] , wherein the intake period is at least 4 weeks.

[12] The composition according to any one of [1] to

[10] , wherein the intake period is at least 8 weeks.

[13] The composition according to any one of [1] to

[10] , wherein the intake period is at least 12 weeks.

[14] The composition according to any one of [1] to

[13] , wherein the composition is a food or drink.

[15] The composition according to any one of [1] to

[14] , wherein the composition is a food with functional claims or a food for specified health use. [Effect of the Invention]

[0009] The composition of the present invention exhibits excellent anti-obesity effect, body fat reduction effect, visceral fat reduction effect or BMI reduction effect. [Modes for Carrying Out the Invention]

[0010] Hereinafter, the present invention will be described in detail. The present invention is not limited to the following embodiments.

[0011] 1. Garcinol The composition of the present invention contains gallocatechol. Gallocatechol is a compound that is a type of polyisoprenylated benzophenone derivative. The gallocatechol used in the present invention is not particularly limited as long as it can be used as a food or drink, and plant-derived gallocatechol or those obtained by synthesis can be used. When using plant-derived gallocatechol in the composition of the present invention, as a gallocatechol source, plant extracts or pulverized powders may be used, or purified products thereof may also be used. As the plant extract, an extract with concentrated gallocatechol and increased concentration may be used. In the present application, the plant extract includes both the extract obtained by extracting the plant with a solvent and the extract obtained by juicing the plant, and includes the concept of drying the extracted or juiced extract and powdering it. Also, in the present application, the pulverized powder of the plant refers to the concept of a powder obtained by drying and pulverizing the plant.

[0012] When using plant-derived gallocatechol, from the viewpoints of having a food experience and being able to safely ingest it and containing a rich amount of gallocatechol, it is particularly preferable to use gallocatechol derived from Garcinia indica. Garcinia indica is a plant (scientific name Garcinia indica) of the genus Garcinia in the family Clusiaceae, and is also called kokum, Indian mangosteen, cobano mangosteen, wild mangosteen, red mangosteen, etc.

[0013] The part of Garcinia indica used is not particularly limited, and leaves, fruits, and other parts can be preferably used in combination. However, from the point of being able to more effectively exert the effects of the present invention, fruits are preferred, and pulp and pericarp are particularly preferred.

[0014] In the present invention, Garcinia indica may be used as is after harvesting, or processed Garcinia indica (Garcinia indica processed product) may be used. When processed Garcinia indica is used, for example, it may be used in the form of powdered or granulated material, or as juice or extract. Juice or extract may be in liquid or slurry form, but it is preferable to use dried powder. Among these, powdered material and extract are preferred, and extract is particularly preferred, as they allow the effects of the present invention to be exhibited more effectively. In the present invention, the term "extract" is a concept that includes dried powder of extract (extract that has been dried and powdered). Garcinia indica processed product may be manufactured by methods commonly known to those skilled in the art, or it may be one that is available on the market.

[0015] In the present invention, Garcinia indica extract can be an extract, a diluted or concentrated extract thereof, or a dried powder thereof. Solvents used for extraction include, for example, water; lower alcohols such as methanol, ethanol, isopropanol, and butanol; lower esters such as ethyl acetate and methyl acetate; acetone; and mixed solvents of these with water. Among these, polar solvents are preferred because they can provide a higher effect, water or ethanol or a mixture of water and ethanol are more preferred, and ethanol is most preferred.

[0016] When extracting with a polar solvent, the extraction method is not particularly limited, and continuous extraction, immersion extraction, countercurrent extraction, etc., can be suitably selected, and any apparatus can be used at room temperature or under reflux heating. The extract can be concentrated and dried into a powder as needed. When the extract is dried into a powder, excipients may be added as needed.

[0017] The composition of the present invention is characterized by being designed so that the daily intake of garcinol is 10 to 50 mg / day. "Designed so that the daily intake of garcinol is 10 to 50 mg / day" means that by taking the oral composition according to the daily intake amount stated on the package or instructions, 10 to 50 mg of garcinol can be ingested per day. The effects of the present invention are efficiently exerted by ingesting 10 to 50 mg of garcinol per day. If the daily intake is less than 10 mg, a sufficient anti-obesity effect will not be achieved. Furthermore, if the daily intake exceeds 50 mg, the anti-obesity effect will not be further reduced, and in some cases, a decrease in the anti-obesity effect may even be observed; therefore, it cannot be said that the anti-obesity effect is efficiently exerted in relation to the dosage of garcinol.

[0018] While there are no particular restrictions on the daily intake of garcinol as long as it is within the range of 10 to 50 mg, from the viewpoint of exerting a sufficient anti-obesity effect and maximizing the anti-obesity effect per dose of garcinol, 10 to 40 mg / day is preferred, 10 to 30 mg / day is more preferred, 10 to 25 mg / day is even more preferred, 10 to 22 mg / day is even more preferred, 10 to 20 mg / day is particularly preferred, and 10 to 18 mg / day is most preferred.

[0019] The composition of the present invention may be appropriately designed so that the daily intake of garcinol falls within the above range, and may be consumed in one dose or in multiple doses. That is, for example, it can be contained in one packaging container or divided into two to four packaging containers to represent one day's supply.

[0020] The packaging form is not particularly limited and can be appropriately selected depending on the dosage form, etc., but examples include blister packs such as PTP; strip packaging; heat seal; aluminum pouch; film packaging using plastic or synthetic resin; glass containers such as vials; plastic containers such as ampoules, etc.

[0021] While there are no particular limitations on the duration of intake of the composition of the present invention, from the viewpoint of exhibiting the effects of the present invention more significantly, the intake period is preferably at least 4 weeks, more preferably at least 8 weeks, and most preferably at least 12 weeks. By taking a low dose over a long period, excellent anti-obesity effects, body fat reduction effects, visceral fat reduction effects, or BMI reduction effects can be expected. However, even if the daily intake amount exceeds the particularly preferred range described in this application when the intake period is 4 weeks or more, 8 weeks or more, or 12 weeks or more, the anti-obesity effect will not improve beyond the range when the daily intake amount is within the particularly preferred range described in this application.

[0022] The garcinol content in the composition of the present invention can be measured by HPLC. For example, it can be measured as follows using an HPLC analyzer (with ultraviolet absorption detector), an analytical column manufactured by Imtakt Corporation (Imtakt Unison UK-C18 HT3μm φ3×150mm), and a membrane filter (0.45μm). Note that any instrument with equivalent functionality can be substituted.

[0023] [Standard product] Garcinol (Funakoshi Co., Ltd.)

[0024] [Reagents used] Acetic acid (special grade), acetonitrile (HPLC grade). For reagents, any equivalent purity product can be used as a substitute.

[0025] [Preparation of standard solutions] After accurately weighing approximately 10 mg of the standard, dissolve it in acetonitrile to prepare solutions with concentrations of 0.02, 0.04, and 0.2 mg / mL. Filter these solutions through a membrane filter to obtain the standard solutions. If necessary, the samples may be treated to remove impurities or otherwise adjust them to suit the separation capabilities of the instrument.

[0026] [Preparation of sample solution] If the sample to be measured is solid, the sample should be made homogenized by grinding it in a mortar and pestle, then approximately 50 mg should be accurately weighed out, acetonitrile should be added to make exactly 50 mL, and the solution should be filtered through a membrane filter to obtain the sample solution. If the sample is liquid, the amount should be adjusted appropriately according to the garcinol concentration in the sample, acetonitrile should be added to make exactly 50 mL, and the solution should be filtered through a membrane filter to obtain the sample solution.

[0027] [HPLC operating conditions] Analytical column: Imtakt Unison UK-C18 HT3μm φ3×150mm Column temperature: 40℃ Injection volume: 5μL Flow rate: 1.0mL / min Measurement wavelength: 350nm Mobile phase A: 0.1% aqueous acetic acid solution Mobile phase B: Acetonitrile

[0028] The gradient conditions are shown in Table 1.

[0029] [Table 1]

[0030] By analyzing under the above conditions, chromatograms of the standard solution and the sample solution are obtained. A calibration curve is created from the garcinol peak area and concentration of the standard solution, and the garcinol concentration (mg / mL) in the sample solution is determined from the calibration curve, thereby measuring the garcinol content in the composition.

[0031] 2. Oral composition The oral composition of the present invention may contain other components besides garcinol. Examples of such other components include sugars, vitamins, minerals, proteins, dietary fiber such as insoluble dietary fiber, plants or processed plant products, yeast, etc. Furthermore, it may contain, if necessary, sweeteners, acidulants, colorants, thickeners, glazing agents, lubricants, excipients, anticaking agents, nutritional supplements, binders, lubricants, stabilizers, diluents, bulking agents, emulsifiers, food additives, seasonings, etc., which are commonly used in the food industry.

[0032] Examples of the oral composition of the present invention include tablets, capsules, powders, granules, liquids, granular preparations, rod-shaped preparations, plate-shaped preparations, block-shaped preparations, solid preparations, round preparations, paste-like preparations, cream-like preparations, caplet-like preparations, gel-like preparations, chewable preparations, stick-shaped preparations, and the like. Among these forms, tablets, capsules, powders, granules, and liquid preparations are preferred from the viewpoint of ease of administration.

[0033] The oral composition of the present invention can take the form of a pharmaceutical product (including quasi-drugs) or a food or beverage. Among these, a food or beverage is particularly preferred because it can be easily consumed in daily life.

[0034] Examples of foods and beverages of the present invention include general foods, nutritional functional foods, functional foods whose efficacy has been approved by a designated institution, and so-called health foods such as foods for specified health uses. Foods that display efficacy are sometimes collectively referred to as "health functional foods" or "functional foods." When the oral composition of the present invention is a food or beverage, it is particularly preferable that it be a functional food or a food for specified health uses, from the viewpoint of being able to communicate the effects of the present invention to consumers.

[0035] The present invention does not particularly limit the food and beverages, but examples include: milk and dairy products; beverages such as soft drinks, fruit juices, milk beverages, alcoholic beverages, sports drinks, and nutritional drinks; seasonings; alcoholic beverages; processed agricultural and forestry products; confectionery and bread; flour and noodles; processed marine products; processed livestock products; oils and fats; frozen prepared foods; retort foods; instant foods; food ingredients; and supplements. Examples of supplement forms include tablets, capsules, powders, granules, and liquids.

[0036] 3. Oral compositions used for anti-obesity and other purposes. The oral composition of the present invention has anti-obesity effects, body fat reduction effects, visceral fat reduction effects, or BMI reduction effects, and can therefore be used as (1) an anti-obesity composition, (2) a body fat reduction composition, (3) a visceral fat reduction composition, and (4) a BMI (Body Mass Index) reduction composition.

[0037] In the present invention, (1) "anti-obesity" encompasses the effect of suppressing (maintaining) the increase in body weight or body fat and the effect of reducing body weight or body fat, and is a concept that encompasses not only the effect on patients with obesity as a disease, but also the effect of suppressing or reducing the increase in body weight and body fat in overweight individuals, as well as diet and slimming effects for cosmetic purposes.

[0038] In this application, "body fat" refers to fat in the body and is a general term for visceral fat and subcutaneous fat. In other words, in this invention, (2) "body fat reduction" means the action of reducing the amount of body fat (visceral fat or subcutaneous fat; abdominal fat and total abdominal fat are also included in body fat).

[0039] In the present invention, (3) "reduction of visceral fat" means the effect of reducing the amount of visceral fat.

[0040] In the present invention, (4) "reduction of BMI" means reducing the value of BMI.

[0041] If the oral composition of the present invention is an oral composition used for any of the functions (1) to (4) described above, it is not particularly limited as long as it can be distinguished from other products in that it is used for any of the functions (1) to (4). For example, if any of the functions (1) to (4) are displayed on the product itself, packaging, instructions, or promotional materials (advertising media), it is included in the scope of the present invention. The oral composition used for any of the functions (1) to (4) of the present invention may display garcinol as the active ingredient, but is not limited to products in which garcinol is displayed as the active ingredient on the product packaging, etc. For example, it may not specify an active ingredient. Furthermore, even general foods are included in the scope of the present invention if they are manufactured and sold with the use of (1) to (4) in mind. For example, foods that are sold with testimonials on a website, etc., mentioning the maintenance and / or improvement of any of the functions (1) to (4) as personal impressions of people who have consumed them are also included in the scope of the present invention. Furthermore, the scope of the present invention also includes functional foods in which garcinol is a functionally active ingredient, and which use papers or other documents demonstrating the maintenance and / or improvement of any of the functions (1) to (4) as the scientific basis for the functionality, and which have a function related to any of (1) to (4) as the notified statement.

[0042] As described above, oral compositions used for any of the functions (1) to (4) include foods and beverages that display a claim that they have one or more functions selected from anti-obesity, body fat reduction, visceral fat reduction, and BMI reduction. It is particularly preferable that such foods and beverages be foods with functional claims or foods for specified health uses.

[0043] Food and beverages that display that they have one or more functions selected from (1) to (4) include, for example, food and beverages that make claims that appeal to people who are concerned about obesity or body fat, such as "for overweight people," "for people concerned about obesity," "for people concerned about their waistline," "for people concerned about their weight," "for people concerned about abdominal fat (visceral fat and subcutaneous fat, etc.)," ​​"for people concerned about their BMI," etc., as well as food and beverages that display that they have a specific function, such as "helps to lose weight," "helps to reduce body fat," "helps to reduce abdominal fat (visceral fat, subcutaneous fat, total abdominal fat, etc.)," ​​"helps to reduce waist circumference," "helps to lower BMI," "helps to overcome obesity," "makes it easier to reduce fat," "helps with dieting," "supports weight loss," "supports body fat reduction," "supports abdominal fat (visceral fat, subcutaneous fat, total abdominal fat, etc.)," ​​"supports reducing waist circumference," "supports lower BMI," "supports overweight recovery," "supports fat reduction," "supports dieting," etc. [Examples]

[0044] The present invention will be described below based on examples. However, the present invention is not limited to the following examples. Unless otherwise specified, "parts" below refers to "parts by mass" and "%" refers to "percentage by mass".

[0045] 1. Clinical Trials The clinical trials described below confirmed that garcinol exhibits anti-obesity effects when the daily intake falls within a specific range.

[0046] 1-1. Subjects and Methods 1) Experimental design This study was conducted as a randomized, double-blind, placebo-controlled, parallel-group comparative trial (allocation ratio: 1:1) lasting a total of 13 weeks, consisting of a pre-observation period (1 week) and an intake period (12 weeks).

[0047] 2) Subjects and setting This study included healthy adults who met the following selection criteria and did not violate any exclusion criteria. Prior to the start of the study, participants were given a thorough explanation of the study and provided written consent. Selection criteria: (1) Healthy Japanese men and women aged 20 to under 65 on the date of obtaining consent; (2) Individuals with a BMI of 25 or higher but under 30; (3) Individuals who have received a full explanation of the purpose and content of this study, have the capacity to give consent, fully understand it, voluntarily volunteer to participate, and give written consent to participate in the study. Exclusion criteria: (1) Individuals who regularly use pharmaceuticals, (2) Individuals with a history of serious liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease, or other metabolic disease, (3) Individuals with implanted medical devices such as cardiac pacemakers or implantable cardioverter-defibrillators, (4) Individuals with metal implants in the CT scan measurement area due to surgery, etc., (5) Individuals with claustrophobia that interferes with CT scan imaging, (6) Individuals who have declared an allergy to the ingredients of the research food, 7) Individuals with a history of digestive diseases or digestive surgery that affect digestion and absorption; (8) Individuals who are obese, have hyperglycemia, hyperlipidemia, or are unable to stop taking health foods or supplements (including Foods for Specified Health Uses and Foods with Function Claims) that may affect lipid metabolism; (9) Individuals who are unable to abstain from alcohol for two days prior to screening tests or each test; (10) Individuals with a history of drug dependence or alcohol dependence, or a current medical condition; (11) Individuals who have been diagnosed with familial hyperlipidemia; (12) Individuals who consume 20% or more pure alcohol equivalent four or more days a week. (13) Individuals who have a habit of consuming more than g / day of alcohol, individuals with extremely irregular eating habits, shift workers or night shift workers, (14) Individuals deemed unsuitable as research subjects by the principal investigator based on clinical tests performed during screening, (15) Individuals who have had blood drawn or donated more than 200 mL within one month of obtaining consent, or more than 400 mL within three months, (16) Pregnant individuals, individuals intending to become pregnant during the research period, or breastfeeding individuals, (17) Individuals currently participating in or intending to participate in other studies (tests) involving the intake of other foods or the use of pharmaceuticals, or studies (tests) involving the application of cosmetics, etc., (18) Others deemed unsuitable as research subjects by the principal investigator.

[0048] 3) Intervention During the intake period, the test food (Example 1) was administered as an intervention. The test food (Comparative Example 1) was a tablet made by mixing Indian mangosteen extract (Sabinsa Japan Corporation) with reduced maltose, cellulose, calcium stearate, and silicon dioxide. The control food was a modified version of the test food, in which the Indian mangosteen extract was replaced with caramel coloring and the amount of reduced maltose was adjusted, so that it could not be distinguished from the test food by appearance. The daily intake for both the test food and the control food was designed to be 250 mg x 2 tablets. During the intake period, subjects were given one sachet (2 tablets) of the test food (test food group received the test food, and the control food group received the control food) once a day with water or lukewarm water. Table 1 shows the energy and nutritional values ​​per daily serving of the test food. The amount of garcinol derived from Indian mangosteen contained in the test food was 18.0 mg per daily serving.

[0049] 4) Examination items The primary endpoint was abdominal visceral fat area, and secondary endpoints included abdominal subcutaneous fat area, total abdominal fat area, weight, BMI, body fat percentage, body fat mass, waist circumference, and a free-response questionnaire regarding subjective feelings. Evaluations were conducted a total of four times: before intake, 4 weeks after intake, 8 weeks after intake, and 12 weeks after intake. However, since abdominal visceral fat area, abdominal subcutaneous fat area, and total abdominal fat area were measured and evaluated using CT scans (Hitachi, Ltd.: Supria), the measurement was limited to three times, excluding the 4-week mark, for the protection of the subjects. Body fat percentage and body fat mass were measured and evaluated using impedance analysis (InBody Japan Inc.: InBody470). Participants were given a food diary and a participant diary, and were instructed to fill in the following survey items daily from one week before the start of intake throughout the intake period. In particular, for the first day of intake and the three days before each test during the intake period, participants were instructed to record their meals in detail, and a nutritionist calculated nutrient intake using nutrition management software (Kenpakusha Co., Ltd.: Excel Nutrition-kun ver. 9). Alcohol intake was also calculated separately. Survey items: (1) Intake of research foods (2) Presence or absence of changes in physical condition (3) Presence or absence of menstruation (women only) (4) Presence or absence of bowel movements (5) Presence or absence of diarrhea symptoms (6) Number of steps taken per day (7) Bedtime (8) Presence or absence of changes in lifestyle (9) Use of pharmaceuticals (excluding nutritional drinks, newly designated quasi-drugs, and newly defined quasi-drugs) (10) Dietary content (including supplements, health foods, nutritional drinks, and alcohol)

[0050] 5) Number of cases The target number of cases in this study is the change in abdominal visceral fat area from before intake in a report on the anti-obesity effect of continuous intake of kudzu flower extract as an example of a functional food [control group: 0 ± 16 cm]. 2 , Test food group -12±14 cm 2 Based on the above, the significance level was set at 0.05 and the power at 0.95, and considering dropouts and discontinuations, the group size was set at 50 people per group (100 people in total).

[0051] 6) Test Method This study recruited paid volunteers, and the principal investigator enrolled participants according to selection and exclusion criteria. A statistical analyst used computer-generated random numbers to assign participants using a block randomization method (block size 4), with sex, age, BMI, and abdominal visceral fat area as confounding factors. The two assigned groups were then divided into a test food group and a control food group by controllers who were not directly involved in the study. Furthermore, the controllers created and sealed a table (key code) containing the assignment results, and kept it sealed until the key code was disclosed after the analysis participants were determined, thus ensuring blinding to anyone other than the controllers. Additionally, the test food was distributed to participants in plain aluminum bags containing two tablets each, ensuring blinding to both participants and those implementing the intervention. Furthermore, during the study period, participants were instructed to refrain from using any medications or health foods that may affect obesity, hyperglycemia, hyperlipidemia, lipid metabolism, etc., to maintain the same lifestyle as before the start of the study, to avoid excessive alcohol consumption, to not go to bed within two hours of dinner, to refrain from eating any food, including snacks, after 10 PM, to leave at least three hours between meals, and to avoid participating in other studies. In addition, participants were instructed to refrain from barium X-ray examinations within two weeks prior to the CT scan, to refrain from consuming raw fruits, raw vegetables, pickles, and carbonated drinks the day before the CT scan to reduce intestinal gas, to avoid alcohol consumption starting two days before the examination, to refrain from eating or drinking anything other than water after 9 PM the day before the examination, and to refrain from smoking from the time of waking up until the end of the examination on the day of the examination. Participants were required to obtain permission from the principal investigator or co-investigator before using any medications, except in emergencies.

[0052] 7) Statistical analysis The analysis population was defined as a Per-Protocol Set (PPS). Repeated measures ANOVA was performed to examine group and time-point interactions. In addition, unpaired t-tests were used for group comparisons of measured values ​​and changes from baseline for each test. The significance level for all tests was set at 0.05 (two-sided). Statistical analysis was performed using IBM SPSS Statistics 28. Subject characteristics are presented as mean ± standard deviation, and other data as mean ± standard error. No additional analyses were performed.

[0053] 1-2.Results 1) Participants in the analysis The study enrolled 100 participants (51 males and 49 females). There were no dropouts after randomization, and the study began with 100 participants. The intervention was assigned to 50 participants in each group. During the study period, one participant (female) in the control food group dropped out due to meeting the discontinuation criteria (for reasons unrelated to the study, her visits to the clinic were more than 8 days apart before and after each examination), and another participant (female) withdrew for reasons unrelated to the test food, resulting in 98 participants completing the study. In addition, 8 participants were found to meet the rejection criteria after the study, so 90 participants (46 males and 44 females) were included in the analysis. The reasons for rejection and the number of participants were as follows: The reason for rejection was that participants were found to have violated the precautions during the study period (4 participants in the test food group and 4 in the control food group). The analysis was performed for each group according to the original allocation.

[0054] 2) Analysis results Tables 2 and 3 show the analysis results for abdominal visceral fat area, abdominal subcutaneous fat area, total abdominal fat area, body weight, BMI, body fat percentage, body fat mass, and waist circumference. Interactions were observed for abdominal visceral fat area, total abdominal fat area, body weight, BMI, body fat percentage, and body fat mass. When comparing the measured values ​​and changes from baseline for each test between groups, significant differences were found in the changes in body fat percentage and body fat mass after 4 weeks of intake, with the test food group showing significantly lower values ​​compared to the control food group (body fat percentage p = 0.036, body fat mass p = 0.015). Furthermore, significant differences were observed in the changes in abdominal visceral fat area, total abdominal fat area, body weight, BMI, body fat percentage, and body fat mass after 8 weeks of intake, with the test food group showing significantly lower values ​​compared to the control food group (abdominal visceral fat area p = 0.014, total abdominal fat area p = 0.016, body weight p = 0.035, BMI p = 0.034, body fat percentage p = 0.021, body fat mass p = 0.0036). In addition, significant differences were observed in the changes in abdominal visceral fat area, total abdominal fat area, body weight, BMI, body fat percentage, and body fat mass after 12 weeks of intake, with the test food group showing significantly lower values ​​compared to the control food group (abdominal visceral fat area p = 0.029, total abdominal fat area p = 0.020, body weight p = 0.019, BMI p = 0.027, body fat percentage p = 0.0052, body fat mass p = 0.0014).

[0055] 3) Summary From these results, it was revealed that taking garcinol at a daily intake of 10-50 mg / day produces anti-obesity effects, body fat reduction effects, visceral fat reduction effects, and BMI reduction effects.

[0056] [Table 2]

[0057] [Table 3]

[0058] 2. Tablets containing garcinol After mixing the raw materials listed in Table 4, tablets (250 mg) for Examples 2-10 were produced by compressing them using a rotary tablet press. The resulting tablets were designed to provide a daily intake of 4 tablets (1000 mg). Table 4 shows the daily intake of garcinol for each example. All of the resulting tablets exhibited anti-obesity effects, body fat reduction effects, visceral fat reduction effects, and BMI reduction effects. In particular, tablets with a daily intake of 10-18 mg / day of garcinol (Examples 2-5) showed the best anti-obesity effects, body fat reduction effects, visceral fat reduction effects, and BMI reduction effects relative to the dosage of garcinol.

[0059] [Table 4] [Industrial applicability]

[0060] The composition of the present invention exhibits anti-obesity effects, body fat reduction effects, visceral fat reduction effects, and BMI reduction effects, and can therefore be used as a health food such as a functional food or a food for specified health uses, making it industrially useful.

Claims

1. A composition designed to provide a daily intake of 10-50 mg of garcinol for anti-obesity, body fat reduction, visceral fat reduction, or BMI reduction.

2. An oral composition containing garcinol as an active ingredient, The daily intake of garcinol is designed to be between 10 and 50 mg / day. An oral composition that is labeled as having one or more functions selected from anti-obesity, body fat reduction, visceral fat reduction, and BMI reduction.

3. The composition according to claim 1 or 2, wherein the composition is a functional food or a food for specified health uses.

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